Randomized phase-III study of low-dose cytarabine and etoposide + /− all-trans retinoic acid in older unfit patients with NPM1-mutated acute myeloid leukemia
The aim of this randomized clinical trial was to evaluate the impact of all-trans retinoic acid (ATRA) in combination with non-intensive chemotherapy in older unfit patients (> 60 years) with newly diagnosed NPM1-mutated acute myeloid leukemia. Patients were randomized (1:1) to low-dose chemother...
Gespeichert in:
| Hauptverfasser: | , , , , , , , , , , , , , , , , , , , , |
|---|---|
| Dokumenttyp: | Article (Journal) |
| Sprache: | Englisch |
| Veröffentlicht: |
08 September 2023
|
| In: |
Scientific reports
Year: 2023, Jahrgang: 13, Pages: 1-9 |
| ISSN: | 2045-2322 |
| DOI: | 10.1038/s41598-023-41964-y |
| Online-Zugang: | Verlag, kostenfrei, Volltext: https://doi.org/10.1038/s41598-023-41964-y Verlag, kostenfrei, Volltext: https://www.nature.com/articles/s41598-023-41964-y 
|
| Verfasserangaben: | R.F. Schlenk, D. Weber, J. Krzykalla, T. Kindler, G. Wulf, B. Hertenstein, H.R. Salih, T. Südhoff, J. Krauter, U. Martens, S. Wessendorf, V. Runde, H.J. Tischler, M. Bentz, E. Koller, M. Heuser, F. Thol, A. Benner, A. Ganser, K. Döhner & H. Döhner |
MARC
| LEADER | 00000caa a2200000 c 4500 | ||
|---|---|---|---|
| 001 | 1872968619 | ||
| 003 | DE-627 | ||
| 005 | 20240331080358.0 | ||
| 007 | cr uuu---uuuuu | ||
| 008 | 231208s2023 xx |||||o 00| ||eng c | ||
| 024 | 7 | |a 10.1038/s41598-023-41964-y |2 doi | |
| 035 | |a (DE-627)1872968619 | ||
| 035 | |a (DE-599)KXP1872968619 | ||
| 035 | |a (OCoLC)1425208435 | ||
| 040 | |a DE-627 |b ger |c DE-627 |e rda | ||
| 041 | |a eng | ||
| 084 | |a 33 |2 sdnb | ||
| 100 | 1 | |a Schlenk, Richard Friedrich |d 1965- |e VerfasserIn |0 (DE-588)129025380 |0 (DE-627)387778004 |0 (DE-576)297454102 |4 aut | |
| 245 | 1 | 0 | |a Randomized phase-III study of low-dose cytarabine and etoposide + /− all-trans retinoic acid in older unfit patients with NPM1-mutated acute myeloid leukemia |c R.F. Schlenk, D. Weber, J. Krzykalla, T. Kindler, G. Wulf, B. Hertenstein, H.R. Salih, T. Südhoff, J. Krauter, U. Martens, S. Wessendorf, V. Runde, H.J. Tischler, M. Bentz, E. Koller, M. Heuser, F. Thol, A. Benner, A. Ganser, K. Döhner & H. Döhner |
| 264 | 1 | |c 08 September 2023 | |
| 300 | |b Illustrationen | ||
| 300 | |a 9 | ||
| 336 | |a Text |b txt |2 rdacontent | ||
| 337 | |a Computermedien |b c |2 rdamedia | ||
| 338 | |a Online-Ressource |b cr |2 rdacarrier | ||
| 500 | |a Online veröffentlicht: 08. September 2023 | ||
| 500 | |a Gesehen am 08.12.2023 | ||
| 520 | |a The aim of this randomized clinical trial was to evaluate the impact of all-trans retinoic acid (ATRA) in combination with non-intensive chemotherapy in older unfit patients (> 60 years) with newly diagnosed NPM1-mutated acute myeloid leukemia. Patients were randomized (1:1) to low-dose chemotherapy with or without open-label ATRA 45 mg/m2, days 8-28; the dose of ATRA was reduced to 45 mg/m2, days 8-10 and 15 mg/m2, days 11-28 after 75 patients due to toxicity. Up to 6 cycles of cytarabine 20 mg/day s.c., bid, days 1-7 and etoposide 100 mg/day, p.o. or i.v., days 1-3 with (ATRA) or without ATRA (CONTROL) were intended. The primary endpoint was overall survival (OS). Between May 2011 and September 2016, 144 patients (median age, 77 years; range, 64-92 years) were randomized (72, CONTROL; 72, ATRA). Baseline characteristics were balanced between the two study arms. The median number of treatment cycles was 2 in ATRA and 2.5 in CONTROL. OS was significantly shorter in the ATRA compared to the CONTROL arm (p = 0.023; median OS: 5 months versus 9.2 months, 2-years OS rate: 7% versus 10%, respectively). Rates of CR/CRi were not different between treatment arms; infections were more common in ATRA beyond treatment cycle one. The addition of ATRA to low-dose cytarabine plus etoposide in an older, unfit patient population was not beneficial, but rather led to an inferior outcome. | ||
| 650 | 4 | |a Cancer | |
| 650 | 4 | |a Oncology | |
| 700 | 1 | |a Weber, D. |e VerfasserIn |4 aut | |
| 700 | 1 | |a Krzykalla, J. |e VerfasserIn |4 aut | |
| 700 | 1 | |a Kindler, T. |e VerfasserIn |4 aut | |
| 700 | 1 | |a Wulf, G. |e VerfasserIn |4 aut | |
| 700 | 1 | |a Hertenstein, B. |e VerfasserIn |4 aut | |
| 700 | 1 | |a Salih, H. R. |e VerfasserIn |4 aut | |
| 700 | 1 | |a Südhoff, T. |e VerfasserIn |4 aut | |
| 700 | 1 | |a Krauter, J. |e VerfasserIn |4 aut | |
| 700 | 1 | |a Martens, U. |e VerfasserIn |4 aut | |
| 700 | 1 | |a Wessendorf, S. |e VerfasserIn |4 aut | |
| 700 | 1 | |a Runde, V. |e VerfasserIn |4 aut | |
| 700 | 1 | |a Tischler, H. J. |e VerfasserIn |4 aut | |
| 700 | 1 | |a Bentz, M. |e VerfasserIn |4 aut | |
| 700 | 1 | |a Koller, E. |e VerfasserIn |4 aut | |
| 700 | 1 | |a Heuser, M. |e VerfasserIn |4 aut | |
| 700 | 1 | |a Thol, F. |e VerfasserIn |4 aut | |
| 700 | 1 | |a Benner, Axel |d 1959- |e VerfasserIn |0 (DE-588)106584686X |0 (DE-627)81687221X |0 (DE-576)425536602 |4 aut | |
| 700 | 1 | |a Ganser, A. |e VerfasserIn |4 aut | |
| 700 | 1 | |a Döhner, K. |e VerfasserIn |4 aut | |
| 700 | 1 | |a Döhner, H. |e VerfasserIn |4 aut | |
| 773 | 0 | 8 | |i Enthalten in |t Scientific reports |d [London] : Springer Nature, 2011 |g 13(2023), Artikel-ID 14809, Seite 1-9 |h Online-Ressource |w (DE-627)663366712 |w (DE-600)2615211-3 |w (DE-576)346641179 |x 2045-2322 |7 nnas |a Randomized phase-III study of low-dose cytarabine and etoposide + /− all-trans retinoic acid in older unfit patients with NPM1-mutated acute myeloid leukemia |
| 773 | 1 | 8 | |g volume:13 |g year:2023 |g elocationid:14809 |g pages:1-9 |g extent:9 |a Randomized phase-III study of low-dose cytarabine and etoposide + /− all-trans retinoic acid in older unfit patients with NPM1-mutated acute myeloid leukemia |
| 856 | 4 | 0 | |u https://doi.org/10.1038/s41598-023-41964-y |x Verlag |x Resolving-System |z kostenfrei |3 Volltext |
| 856 | 4 | 0 | |u https://www.nature.com/articles/s41598-023-41964-y |x Verlag |z kostenfrei |3 Volltext |
| 951 | |a AR | ||
| 992 | |a 20231208 | ||
| 993 | |a Article | ||
| 994 | |a 2023 | ||
| 998 | |g 106584686X |a Benner, Axel |m 106584686X:Benner, Axel |d 50000 |e 50000PB106584686X |k 0/50000/ |p 18 | ||
| 998 | |g 129025380 |a Schlenk, Richard Friedrich |m 129025380:Schlenk, Richard Friedrich |d 910000 |d 910100 |e 910000PS129025380 |e 910100PS129025380 |k 0/910000/ |k 1/910000/910100/ |p 1 |x j | ||
| 999 | |a KXP-PPN1872968619 |e 4429056935 | ||
| BIB | |a Y | ||
| SER | |a journal | ||
| JSO | |a {"type":{"bibl":"article-journal","media":"Online-Ressource"},"title":[{"title_sort":"Randomized phase-III study of low-dose cytarabine and etoposide + /− all-trans retinoic acid in older unfit patients with NPM1-mutated acute myeloid leukemia","title":"Randomized phase-III study of low-dose cytarabine and etoposide + /− all-trans retinoic acid in older unfit patients with NPM1-mutated acute myeloid leukemia"}],"physDesc":[{"extent":"9 S.","noteIll":"Illustrationen"}],"id":{"eki":["1872968619"],"doi":["10.1038/s41598-023-41964-y"]},"relHost":[{"title":[{"title":"Scientific reports","title_sort":"Scientific reports"}],"id":{"eki":["663366712"],"issn":["2045-2322"],"zdb":["2615211-3"]},"physDesc":[{"extent":"Online-Ressource"}],"origin":[{"dateIssuedDisp":"2011-","publisher":"Springer Nature ; Nature Publishing Group","publisherPlace":"[London] ; London","dateIssuedKey":"2011"}],"recId":"663366712","disp":"Randomized phase-III study of low-dose cytarabine and etoposide + /− all-trans retinoic acid in older unfit patients with NPM1-mutated acute myeloid leukemiaScientific reports","type":{"media":"Online-Ressource","bibl":"periodical"},"language":["eng"],"part":{"text":"13(2023), Artikel-ID 14809, Seite 1-9","extent":"9","pages":"1-9","volume":"13","year":"2023"},"pubHistory":["1, article number 1 (2011)-"],"note":["Gesehen am 12.07.24"]}],"origin":[{"dateIssuedDisp":"08 September 2023","dateIssuedKey":"2023"}],"language":["eng"],"name":{"displayForm":["R.F. Schlenk, D. Weber, J. Krzykalla, T. Kindler, G. Wulf, B. Hertenstein, H.R. Salih, T. Südhoff, J. Krauter, U. Martens, S. Wessendorf, V. Runde, H.J. Tischler, M. Bentz, E. Koller, M. Heuser, F. Thol, A. Benner, A. Ganser, K. Döhner & H. Döhner"]},"recId":"1872968619","person":[{"role":"aut","family":"Schlenk","given":"Richard Friedrich","display":"Schlenk, Richard Friedrich"},{"role":"aut","family":"Weber","display":"Weber, D.","given":"D."},{"family":"Krzykalla","role":"aut","display":"Krzykalla, J.","given":"J."},{"family":"Kindler","role":"aut","display":"Kindler, T.","given":"T."},{"given":"G.","display":"Wulf, G.","role":"aut","family":"Wulf"},{"given":"B.","display":"Hertenstein, B.","role":"aut","family":"Hertenstein"},{"given":"H. R.","display":"Salih, H. R.","role":"aut","family":"Salih"},{"family":"Südhoff","role":"aut","display":"Südhoff, T.","given":"T."},{"display":"Krauter, J.","given":"J.","role":"aut","family":"Krauter"},{"given":"U.","display":"Martens, U.","family":"Martens","role":"aut"},{"given":"S.","display":"Wessendorf, S.","role":"aut","family":"Wessendorf"},{"display":"Runde, V.","given":"V.","role":"aut","family":"Runde"},{"family":"Tischler","role":"aut","given":"H. J.","display":"Tischler, H. J."},{"role":"aut","family":"Bentz","given":"M.","display":"Bentz, M."},{"role":"aut","family":"Koller","given":"E.","display":"Koller, E."},{"role":"aut","family":"Heuser","given":"M.","display":"Heuser, M."},{"family":"Thol","role":"aut","given":"F.","display":"Thol, F."},{"given":"Axel","display":"Benner, Axel","role":"aut","family":"Benner"},{"given":"A.","display":"Ganser, A.","role":"aut","family":"Ganser"},{"given":"K.","display":"Döhner, K.","family":"Döhner","role":"aut"},{"role":"aut","family":"Döhner","given":"H.","display":"Döhner, H."}],"note":["Online veröffentlicht: 08. September 2023","Gesehen am 08.12.2023"]} | ||
| SRT | |a SCHLENKRICRANDOMIZED0820 | ||